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Changing the Mindset Towards Case Quality, Audits, and Inspections: A Practical Approach
Session Chair(s)
Maria C. Koster, PharmD
Senior Director International Relations
Vigilex, part of the Xendo Group, Netherlands
Alternatives to Traditional Audit Methodologies: Effective Auditing While Risk-Based
Learning Objective : Discuss different approaches taken by various companies and their audit functions in different geographic areas.
Speaker(s)
Ensuring Standardized Case Quality in Safety and Pharmacovigilance Services through Web-Based Systems
Drew Kilpatrick, PhD
INC Research, United Kingdom
Vice President, Safety and Pharmacovigilance
Alternatives to Traditional Audit Methodologies: Effective Auditing While Risk-Based
Maria C. Koster, PharmD
Vigilex, part of the Xendo Group, Netherlands
Senior Director International Relations
Struggling with Three Inspectors From Different Worlds: Reality and Idealism
Teiki Iwaoka, PhD, MS
Rockhill Consulting, Japan
Director, Pharmacovigilance, Clinical Development
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